This week's biotech landscape features key FDA approvals, clinical holds and go-aheads, trial discontinuations, and clinical trial data readouts across key therapeutic areas such as Endometrial cancer, Colorectal cancer, Weight Management, Acne, and Duchenne muscular dystrophy. Let us unpack the key developments and milestones in the biotech space this week.FDA Approvals & RejectionsIntellia Gets FDA Green Light to Resume MAGNITUDE-2 Phase 3 TrialIntellia Therapeutics, Inc. (NTLA) said the U.S. FDA has lif ...

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades, downgrades and initiations, please see our analyst ratings page.Considering buying CALC stock? Here’s what analysts think: Photo via Shutterstock ...

CalciMedica, Inc. (NASDAQ:CALC) shares are down on Wednesday after the company announced the discontinuation of its Phase 2 KOURAGE clinical trial.The trial was evaluating Auxora in patients with Stage 2 or Stage 3 acute kidney injury (AKI) with associated acute hypoxemic respiratory failure (AHRF). Data was expected in the first half of 2026.The stock is trading lower with a session volume of 23.27 million, compared to the average volume of 84.063 thousand.CalciMedica Halts KOURAGE Trial Due to Safety Conc ...

Safety concern warrants reevaluation of study design, including enrollment criteria About CalciMedica CalciMedica is a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory and immunologic diseases. CalciMedica's proprietary technology targets the inhibition of CRAC channels to modulate the immune response and protect against tissue cell injury, with the potential to provide therapeutic benefits in in serious and life ...

Core Insights - Airbus SE has secured a firm order from China Aircraft Leasing Group Holdings Limited for 30 A320neo aircraft, marking CALC's fifth order with Airbus and increasing its total orders to 282, including 203 from the A320neo family [1][10] Group 1: Aircraft Specifications and Demand - The A320neo is a highly popular single-aisle aircraft, accommodating up to 194 passengers and offering up to 20% lower fuel consumption and CO2 emissions compared to earlier models, with a range of 3,400 nautical miles [2][10] - The aircraft can operate with up to 50% Sustainable Aviation Fuel, aiming for 100% by 2030, which enhances its appeal and contributes to strong demand and growth in orders [2][3] Group 2: Market Trends and Future Outlook - Rising air passenger traffic and the demand for modern, fuel-efficient aircraft are driving growth in the commercial aviation market, with Airbus estimating a demand for 43,420 new aircraft deliveries over the next 20 years [4][5] - This trend supports industry expansion and the replacement of older, less efficient aircraft, indicating strong long-term revenue prospects for Airbus [5] Group 3: Competitor Insights - Other aerospace companies like Boeing and Embraer are also expected to benefit from rising jet demand, with Boeing delivering 160 commercial aircraft in Q3 2025 and Embraer delivering 20 new jets in the same period [6][7] - Boeing has a long-term earnings growth rate of 31.33%, while Embraer has a growth rate of 14.32%, indicating positive financial outlooks for these companies as well [7][8] Group 4: Stock Performance - Over the past six months, Airbus shares have increased by 14.7%, outperforming the industry growth of 7.5% [9]

Financial Performance - The company reported a net loss of $18.8 million for the nine months ended September 30, 2025, with total operating expenses of $18.7 million and interest expense of $1.1 million[151]. - Net loss for the three months ended September 30, 2025, was $7.8 million, a 39% increase from a net loss of $5.6 million in 2024[167]. - Total operating expenses for the nine months ended September 30, 2025, were $18.7 million, a 4% increase from $18.0 million in 2024[171]. - Other income (expense) for the nine months ended September 30, 2025, was an expense of $0.1 million, compared to income of $8.6 million in 2024, reflecting an increase in expenses of $8.7 million[173]. - Cash used in operating activities was $16.3 million for the nine months ended September 30, 2025, primarily due to the net loss and non-cash items totaling $2.2 million[192]. - The company has experienced significant operating losses since inception, except for the three-month period ending March 31, 2024[190]. Cash and Funding - As of September 30, 2025, the company had an accumulated deficit of $178.6 million and $14.1 million in cash, cash equivalents, and short-term investments, which are expected to fund operations into the second half of 2026[151]. - The company expects its cash resources may not be sufficient to fund operations beyond the second half of 2026, indicating substantial doubt about its ability to continue as a going concern[176]. - The company will need to raise substantial additional capital to complete the development and commercialization of its product candidates[177]. - The company expects to finance future cash requirements through a combination of existing cash, equity offerings, and debt financing, but there is no assurance that additional capital can be raised[182]. - The company entered into a Loan Agreement for initial gross proceeds of $10.0 million on February 28, 2025[175]. - Cash provided by financing activities for the nine months ended September 30, 2025, was $11.5 million, primarily from debt financing of $9.7 million[195]. - The company entered into a Loan Agreement for growth capital loans totaling up to $32.5 million, with the first tranche of $10 million funded on the closing date[189]. Research and Development - The company has conducted multiple Phase 2 clinical trials for its lead product candidate, Auxora, demonstrating a reduction in organ damage and time to recovery in patients[141]. - The company anticipates significant increases in research and development expenses as it continues to advance its product candidates and seek regulatory approvals[158]. - Research and development expenses increased by 9% to $3.9 million for the three months ended September 30, 2025, compared to $3.6 million for the same period in 2024[168]. - Research and development expenses for the nine months ended September 30, 2025, were $12.1 million, a 14% increase from $10.6 million in 2024[171]. - The company has not generated any product revenue and does not expect to do so until successful development and regulatory approval of its product candidates[153]. - The company has paused IND enabling preclinical work on certain compounds to focus resources on clinical programs, pending additional funding[142]. Regulatory and Compliance - The company expects to finalize the pivotal trial design for Auxora in acute pancreatitis in the first half of 2026, following positive engagement with the FDA[141]. - The company is classified as an emerging growth company and will cease this status on December 31, 2025, allowing it to delay adopting new accounting standards until then[207]. - The company is also a smaller reporting company, with a market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million in the most recently completed fiscal year[208]. Accounting and Estimates - The company has not experienced material differences between accrued costs and actual costs incurred since inception, indicating effective cost estimation practices[202]. - Clinical trial expenses are accrued based on patient enrollment and contracted amounts, with adjustments made for changes in trial protocols or scope[203]. - The fair value of the promissory note is estimated using a discounted cash flow analysis, with updates to assumptions potentially impacting results significantly[205]. - Common warrants are valued using the Black-Scholes model, with various scenarios considered that could affect fair value based on updated assumptions[206]. - The company records estimated research and development costs based on services provided but not yet invoiced, impacting accrued liabilities and expenses[201]. - The company capitalizes payments made prior to receiving goods or services for research and development until they are received[201]. - The company utilizes estimates for accrued liabilities and prepaid expenses, adjusting them as actual costs become known[202]. - No recently adopted accounting pronouncements were reported, indicating stability in accounting practices[209].

Exhibit 99.1 LA JOLLA, Calif., November 12, 2025 – CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today reported financial results for the third quarter ended September 30, 2025 and provided clinical and corporate updates. "Enrollment continues in our Phase 2 KOURAGE trial evaluating Auxor ...

Core Insights - CalciMedica is advancing its clinical programs, particularly the Phase 2 KOURAGE trial for Auxora in acute kidney injury (AKI) with respiratory failure, with data expected in the first half of 2026 [1][5] - Positive discussions with the FDA regarding a pivotal trial in acute pancreatitis (AP) are ongoing, with final trial design anticipated in the first half of 2026 [1][2] - The company's cash position is projected to support operations into the second half of 2026 [1][8] Clinical Updates - Enrollment in the KOURAGE trial is ongoing, targeting 150 patients with Stage 2 or Stage 3 AKI with respiratory failure, with results expected in 1H 2026 [5] - Recent animal model data presented at ASN Kidney Week 2025 supports the efficacy of Auxora in improving kidney function and reducing renal injury [5][7] - Collaboration with Telperian aims to utilize AI-driven analytics to enhance the design of the pivotal trial in AP [2][6] Financial Results - As of September 30, 2025, CalciMedica reported cash, cash equivalents, and short-term investments totaling $14.1 million [8] - Research and development expenses for Q3 2025 were $3.9 million, up from $3.6 million in Q3 2024, primarily due to increased clinical trial activities [9] - General and administrative expenses decreased to $1.8 million in Q3 2025 from $2.2 million in Q3 2024 [10] - The net loss for Q3 2025 was $7.8 million, or $0.52 per share, compared to a net loss of $5.6 million, or $0.50 per share, in Q3 2024 [12]

Accessibility StatementSkip Navigation Preclinical data support CRAC channel inhibitor, CM5480, as a potential first-in-class, differentiated therapy for pulmonary arterial hypertension (PAH), both as monotherapy and in combination with existing treatments Cardiac benefit supports the mechanistic rationale for CRAC channel inhibition in acute kidney injury (AKI), being evaluated in the Phase 2 KOURAGE trial with data expected in 1H 2026 LA JOLLA, Calif., Nov. 12, 2025/PRNewswire/ -- CalciMedica Inc. ("Calci ...

Core Insights - CalciMedica's Auxora has shown significant potential in reducing IL-17-related inflammation and improving kidney function in a rat model of acute kidney injury (AKI) [1][3][6] - The company is currently evaluating Auxora in the Phase 2 KOURAGE trial for severe AKI with respiratory failure, reinforcing its therapeutic potential [1][4] Study Findings - In a study involving rat models of ischemia/reperfusion-induced AKI, Auxora (16 mg/kg) was administered intravenously, leading to a significant increase in glomerular filtration rate (GFR) and a reduction in renal injury [2][6] - Three-day dosing of Auxora resulted in a 64% reduction in Th-17 cells in the kidney and a 59% reduction in the lung, along with a 69% decrease in IL-6-producing CD4 cells [6] Mechanistic Support - The study provided strong mechanistic support for Auxora as a treatment for severe AKI with acute hypoxemic respiratory failure (AHRF), highlighting the correlation between elevated IL-17 levels and adverse kidney events [3][4] - Down-regulation of IL-17 may be crucial in mitigating multi-organ failure, which is common in critically ill patients with severe AKI [3] Company Overview - CalciMedica is a clinical-stage biopharmaceutical company focused on developing CRAC channel inhibition therapies for inflammatory and immunologic diseases, with a proprietary technology aimed at modulating immune responses [5][7] - The company has conducted multiple efficacy clinical trials for Auxora, which has been well-tolerated in over 350 critically ill patients [7]